Effect of Intranasal Neuropeptide on Emotion Perception in Trait Anxiety

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01551303
Recruitment Status : Completed
First Posted : March 12, 2012
Results First Posted : June 30, 2014
Last Update Posted : June 30, 2014
Information provided by (Responsible Party):
Elizabeth A. Hoge, MD, Massachusetts General Hospital

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Basic Science
Condition: Social Intelligence
Interventions: Drug: Oxytocin
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Adults aged 18 to 65 were recruited to the Massachusetts General Hospital through local email and print media advertising from March 2011 to September 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No enrolled participants were excluded before group assignment.

Reporting Groups
Oxytocin Oxytocin, 30 IU in 0.77 ml, intranasal
Placebo Placebo, 0.77 ml, intranasal

Participant Flow:   Overall Study
    Oxytocin   Placebo
STARTED   25   22 
COMPLETED   21   15 
failed awareness check on vision test                4                7 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
Oxytocin Oxytocin, 30 IU in 0.77 ml, intranasal
Placebo Placebo, 0.77 ml, intranasal
Total Total of all reporting groups

Baseline Measures
   Oxytocin   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 25   22   47 
[Units: Years]
Mean (Standard Deviation)
 42.24  (11.61)   44.50  (9.62)   43.30  (10.67) 
[Units: Participants]
Female   10   8   18 
Male   15   14   29 
Region of Enrollment 
[Units: Participants]
United States   25   22   47 

  Outcome Measures

1.  Primary:   Affective Ratings in Affective Learning Task   [ Time Frame: 30 minutes after drug administration ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Dr. Elizabeth Hoge
Organization: Massachusetts General Hospital
phone: 617-724-0859

Responsible Party: Elizabeth A. Hoge, MD, Massachusetts General Hospital Identifier: NCT01551303     History of Changes
Other Study ID Numbers: 2009P-000387
First Submitted: February 21, 2012
First Posted: March 12, 2012
Results First Submitted: March 26, 2014
Results First Posted: June 30, 2014
Last Update Posted: June 30, 2014